Managing your Research Staff Presenters: Julie Horne, Lawson Health Research Institute Elana Whelan, Western October 11, 2013 Declaration: Julie Horne and Elana Whelan have no actual or potential conflicts of interest in relation to this educational program.

Objectives To highlight points to consider when hiring research staff; To highlight the supervisor’s role and responsibilities for research staff; and To review the approval process and requirements for conducting clinical studies in the hospitals, prior to hiring staff.

Hiring Research Staff Type of Research i.e. Clinical or Academic Relationship Lawson/Hospital (LHSC or SJHC) Western Terms of Employment Temporary employment (one-year renewable contracts) Research job titles are determined by the relationship Compensation - based on funding or UWO Collective Agreement

What to consider when hiring Research Staff Length of funding Responsibilities and duties Hours of work Union vs. Non Union Job posting requirement Salary pay scales

What to consider when hiring Postdocs Letter of appointment for immigration purposes Determination of the Relationship Pay rate guidelines Maximum length of a Postdoc

Hiring Clinical Research Staff Hiring process Recruitment (Internal or external candidates) Non-union Research positions Employee Action Form Standards of Business Conduct/Conflict of Interest Employment Standards Act (ESA)

Supervisor Responsibilities for New Research Staff Review role and expectations Ensure that outcomes are understood Review hours of work, how breaks/lunches and absences will be handled and tracked Regular check-ins Probationary period Performance management Termination/Severance Obligation and (ESA)

Staff Requirements You have hired your research staff and completed the necessary documentation. You have heard that there are expectations for research staff by the employer, the Ministry of Health, and the Ministry of Labour. What are the mandatory requirements that you need to pay attention to? What are some specialty training requirements that may apply to your research staff?

Staff Requirements Documentation and identification Health requirements (if applicable) Privacy & confidentiality – education, agreement Employee orientation - policies and procedures; code of conduct Reporting illness/injuries - Occupational Health & Safety Services departments at each site

Required Staff Training Mandatory Legislated Health & Safety: WHMIS Fire Safety (hospital) Clinical Research (with Patient Contact): N95 Fit Test Infection control Electronic Patient Record (EPR)

Western/Lawson Health & Safety Laboratory: Faculty/Supervisor Responsibilities Seminar General Laboratory Safety & Hazardous Waste Management Biosafety (if applicable) X-ray Safety (if applicable) Health & Safety Committee

Required Approvals You are interested in starting a clinical trial at LHSC or SJHC. You are anxious to start consenting participants. You know that you are able to start recruitment once you receive your….

Approval Process Signed clinical trial agreement with sponsor Research Ethics Board (REB) approval Lawson approval form (R number) Health Canada approval c) Lawson approval form (R number) The Lawson approval process includes: Fully executed agreement with industry sponsors, or data sharing/data transfer/materials transfer agreement with collaborators. An agreement must be in place before any data or research materials/specimens can be sent off site for analysis. These agreements must be tripartite (3 signatories- Lawson, Principal Investigator, sponsor/collaborator) Institutional Sign Off. This signature process is done to provide the ethics committee with an assurance that Lawson is aware of the research proposal, that the Principal Investigator has the qualifications to undertake the work proposed, that they have the resources to undertake the research and that an appropriate agreement/contract will be in place before the study begins. Evidence of UWO ethics approval. This is provided to Lawson by the ethics committee. Health Canada approval letter (if applicable). If your study involves the use of an unapproved medication, device or natural product you may require approval from Health Canada before you begin your study. This may also apply if you are studying a marketed medication or licensed device in an indication that is not part of the Health Canada marketing/licensing approval. If you are unclear whether you may need Health Canada approval for your study please contact Ruth Bullas at x76093. Clinical Research Impact Committee (CRIC) approval. This committee reviews study proposals to determine the impact of research on hospital resources. There are 5 committees – LHSC, SJHC, London Regional Cancer Program, Regional Mental Health Care (London or St. Thomas) or Parkwood hospital. Your information will be sent to the committee at each hospital site you are utilizing in your study. Research Accounting. Regardless of where you hold your research accounts (UWO or Lawson), Lawson will require evidence of adequate funding for your research study. If you were able to secure grant funding you will need to provide a copy of an award letter from the granting agency, acceptable evidence of a successful grant application or budget from an industry sponsor. Once Lawson has all of this documentation, you will be issued your Lawson approval number.

Important Contacts – Priceless! HR Lawson – Julie Horne ext. 78953 HR Western (Schulich Staff) – Elana Whelan ext. 80388 LHSC HR – Alycia Hummel ext. 32566 SJHC HR – Karen Topfer ext. 65599